Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)
Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)
研究概览
详细说明
We will conduct an open label, multi-center study of naïve AMD patients that are identified early upon disease progression (had a normal VA, FA or OCT within 4 months prior to entry) to assess if treating with ranibizumab monthly can restore all patients to their baseline vision pre-AMD. Recent randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with ranibizumab in patients with subfoveal CNV from AMD leads to stabilization of vision in over 90% of patients and improvement in vision in at least a third of the patients and has led to the approval of ranibizumab (0.5 mg) for the treatment of neovascular AMD.
Patients will receive monthly intravitreal ranibizumab injections for 12 months (with dose holding for return to baseline/ 20/20 or better and no evidence of fluid on SD-OCT or FA). All patients will have ETDRS vision and SD-OCT, and complete exam at each monthly visit. Patients will each have a blood analysis for genetics (either during the GALLEY study in which they converted to wet AMD and entered COMPASS or during this study).
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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California
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Bakersfield、California、美国、93309
- California Retina Consultants
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La Jolla、California、美国、92093
- Shiley Eye Center, UCSD
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Santa Barbara、California、美国、93103
- California Retina Consultants
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Texas
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San Antonio、Texas、美国、78240
- Medical Center Ophthalmology Associates
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Naïve wet-AMD within 4 months of disease onset (for GALLEY patients) and within 3 months of disease onset for all others
- Patients that have lost > 5 letters from baseline best vision
- BCVA 20/25-20/320
Exclusion Criteria:
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial which includes an intervention (Patients could be participating in a non-interventional study such as the GALLEY study)
- Juxtafoveal and extrafoveal wet-AMD
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Ranibizumab 0.5 mg
Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year
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0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months
大体时间：Baseline, Month 6 and Month 12
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PI is no longer affiliated with institution.
All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site.
Data from these participants is being reported here.
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Baseline, Month 6 and Month 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months.
大体时间：Baseline, Month 6 and Month 12
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Mean change was measured by letters gained or lost.
A positive number is letters gained, and a negative number is letters lost.
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Baseline, Month 6 and Month 12
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Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months
大体时间：Baseline, Month 6 and Month 12
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Baseline, Month 6 and Month 12
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合作者和调查者
合作者
调查人员
- 学习椅：Henry Ferreyra, MD、University of California, San Diego
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
ranibizumab的临床试验
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Hoffmann-La Roche完全的
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Hoffmann-La Roche招聘中新生血管性年龄相关性黄斑变性 (nAMD)比利时, 大韩民国, 德国, 西班牙, 英国, 澳大利亚, 意大利, 阿根廷, 以色列, 奥地利, 巴西, 法国, 新加坡, 瑞士, 台湾, 火鸡
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Hoffmann-La Roche招聘中新生血管性年龄相关性黄斑变性比利时, 美国, 英国, 意大利, 阿根廷, 西班牙, 以色列, 澳大利亚, 奥地利, 巴西, 德国, 瑞士, 台湾, 法国